Tratamento da leishmaniose cutânea com anfotericina B lipossomal no idoso: ensaio clínico randomizado - Dissertação de Mestrado 2022

Português, Brasil
Introduction: Cutaneous leishmaniasis (CL) is an important public health problem in Brazil, caused mainly by Leishmania (Viannia) braziliensis, representing more than 90% of the total cases. CL is predominantly found in adult males exposed to forest regions. In recent years, however, the epidemiology of CL has changed, affecting women, children, and the elderly. The increased incidence in the elderly results in a therapeutic challenge, since Sbv is not recommended in patients of this age group, nor in patients with heart, liver, or kidney disease, commonly present in senile patients. In this context, liposomal amphotericin B becomes the therapy of choice in this group, with good efficacy and less toxicity. However, there is little experience with its use with AT in CL with some favorable reports in the management of cutaneous and mucosal forms, including those associated with L. braziliensis. Objectives: Determine the efficacy and safety in the treatment of ATL at total doses of 12 mg/kg, 18 mg/kg and 24 mg/kg caused by L. braziliensis in patients over 60 years of age, determine the healing time between the different doses in liposomal amphotericin B in the treatment of ATL in the elderly and to compare the initial D90 and final healing time between the three groups and evaluate the safety between the groups. Methods: The present study was a randomized controlled trial aimed to identify the dose of liposomal amphotericin B associated with the highest cure rate in the elderly group. Twenty-eight patients of both genders, aged 60 years or older, diagnosed with CL and confirmed by detection of L. braziliensis DNA in tissue obtained from classic cutaneous ulcers (rounded or oval lesion, with granular bottom, erythematous raised and infiltrated edges) were selected. The groups were treated with liposomal amphotericin B (AmBisome®) with different total doses: Group 1 (G1) received total dose of 12 mg/kg. Group 2 (G2) received total dose of 18 mg/kg. Group 3
(G3) received a total dose of 24 mg/kg. Clinical and/or laboratory assessments were performed: before the start of therapy, D15, D30, D60, D120, D150 and D180 after the start. Results: The average ages of groups G1, G2 and G3 were: 68.5; 73.3 and 68.1. Concerning the number of lesions, the average of the groups was 1.5, 1.67 and 1.36. The average healing (days) was: 65; 66; 44.6. The treatment failure rates in groups G1, G2 and G3 were 40%, 55.4% and 11% respectively. Regarding side effects, paradoxically G3 had the lowest incidence of side effects (11%). In G2 there was one treatment interruption due to anaphylaxis and one relapse. Conclusions: The highest cure rate found (89%) was in the group that received the total dose of 24 mg/kg with low occurrence of side effects considered mild and indicate that this is the best dose to treat CL in the elderly.
Docente Orientador: 
Palavras-chave: 
1. Cutaneous Leishmaniasis; 2. Liposomal B Amphotericin; 3. Elderly
Banca examinadora: 
Paulo Roberto Lima Machado (Presidente/orientador) Patrícia Tavares Sampaio Veras Fernanda Ventin Prates de Souza Luiz Henrique Santos Guimarães (Suplente)
Ano de publicação: 
2022